There are approximately 6 million people in the United States treated with FXa inhibitors, and there are over 198,000 hospitalizations from FXa inhibitor–associated major bleeding events annually.5,6 FXa inhibitors are blood-thinning medications, meaning they interfere with the body’s normal clotting process. This can contribute to an overall risk of bleeding, ranging from less severe to life-threatening. The reported risk of major bleeding in patients with nonvalvular atrial fibrillation is reported to be 3.6% for rivaroxaban and 1.41% to 2.13% for apixaban.7,8
FXa inhibitor–related major bleeds can present in various sites of the body, such as the brain, gastrointestinal tract, inside the abdominal cavity, lungs, and a variety of other places due to trauma.5 A bleeding event is considered life-threatening when there is a reduction in hemoglobin of at least 2 g/dL, when the bleed is associated with signs or symptoms of hemodynamic compromise, or when there is bleeding into a critical area or organ.9 These major bleeding events are associated with a significantly increased risk for death.5
About 410 patients each day were expected to be hospitalized with an apixaban- or rivaroxaban-related bleed in 2018.9 It is estimated that approximately 70 patients die each day following hospitalization for bleeding related to rivaroxaban or apixaban.6,10,11
Symptoms of FXa bleeds
- Uncontrolled or life-threatening bleeds